臨床研究等提出・公開システム

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor (J2A-MC-GZGW)

A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor (J2A-MC-GZGW)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Not Recruiting

Dec. 19, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Have Type 2 Diabetes (T2D)
Have HbA1c>=7.0% [53 mmol/mol] to <=10.5% [91 mmol/mol]
Have been treated with stable doses of the same formulation of the following for >=90 days prior to screening visit 1 and have maintained the same doses through randomization:

insulin glargine U-100 (100 U/mL) >=0.20 U/kg/QD (units per kilogram per day) or >=15 U/QD alone, or
insulin glargine U-100 (100 U/mL)>=0.20 U/kg/QD or >=15 U/QD in combination with
metformin, or
SGLT-2 inhibitor.
Are of stable body weight (+-5%) for at least 90 days prior to screening visit 1 and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
Have a Body Mass Index (BMI) >=23.0 kg/m^2 at baseline.

Have New York Heart Association functional classification III-IV congestive heart failure.
Have had any of the following cardiovascular conditions within 60 days prior to baseline.

acute myocardial infarction
cerebrovascular accident (stroke), or
hospitalization for congestive heart failure.
Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease
Have had chronic or acute pancreatitis any time.

Both

Type 2 Diabetes

Drug: Orforglipron
Administered orally.
Other Name: LY3502970
Drug: Placebo
Administered orally.

Study Arms
Experimental: Orforglipron Dose 1
Participants will receive orforglipron orally.
Intervention: Drug: Orforglipron
Experimental: Orforglipron Dose 2
Participants will receive orforglipron orally.
Intervention: Drug: Orforglipron
Experimental: Orforglipron Dose 3
Participants will receive orforglipron orally.
Intervention: Drug: Orforglipron
Placebo Comparator: Placebo
Participants will receive placebo orally.
Intervention: Drug: Placebo

Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ]

+81-3-3881-6116

Oct. 27, 2023

Yes

Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Brazil/China/Puerto Rico/Romania/United States